FDA approved Cleveland Diagnostics' IsoPSA assay on November 28 under P200048. The blood test combines total and free PSA from partitioned plasma into a single index. It is indicated for men 50 and older with PSA between 4.0 and 10.0 ng/mL who are being considered for biopsy. The claim is an aid in detecting Grade Group 2 or higher cancer.
FDA received the PMA on December 28, 2020. The 1,796-day review ran just under five years. Cleveland Diagnostics sold IsoPSA as a laboratory-developed test from 2020 and won Medicare coverage while the file sat in review. It also got into the AUA/SUO guideline in 2023 and the NCCN guideline in 2025. Clinical evidence came from a prospective study at 14 US sites. Product code QRF puts the kit in the multi-analyte algorithmic class.
The Cleveland company raised more than $75 million in January 2024, led by Novo Holdings, with a credit facility from Symbiotic Capital. Co-founder Arnon Chait is CEO. For a diagnostics startup, an LDT launch covered payroll through a five-year Class III review.